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NCT00186563 Clinical Trial

A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers

Skin Diseases Clinical Trial

Official title:
Proof-of-concept Study for Bio-marker Assay Validation in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00186563
Other study ID # 79723
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated June 18, 2013

Study information
Verified date June 2013
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study aims to establish a novel approach assisting the rational development of analgesic and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether proteins mediating inflammation and pain can be detected in an experimentally induced inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected from the inflamed skin site via small porous catheters. We wish to establish the expression pattern of different proteins and correlate it with various tests assessing pain.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:1. Age between 21-60. 2. Skin type II or III according to the classification of Fitzpatrick (II: fair skin, always burns, sometimes tans, III: medium skin, sometimes burns, always tans). Exclusion Criteria:1. History of a significant systemic disease, a dermatological disease, bleeding disorder, or chronic pain.

2. Consumption of analgesic drugs. 3. Hypersensitivity to sunlight.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Micro-plasmapheresis

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Martin Angst

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor
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